Good day Anon,
There is some flexibility in the way a 510(k) submission is cleared and how a company actually markets and sells medical devices. The 510(k) application process in the United States is to allow marketing of a device or devices through premarket notification. To answer your questions:
The sponsor/submitter of the 510(k) application does not always have to be the manufacturer of the device. Meaning an entity could achieve 510(k) clearance for a medical device product and then another company could actually manufacture and sell the product under their own being the "legal" Manufacturer of the device. Even though they do not "own" the 510(k) submission or had anything to do with the submission. As an example, Company A could submit a 510(k), get clearance, have the 510(k) associated with Company A. Company A then gives the ability (typically through a contract) for Company B to manufacture and sell the device under their own name. Company B would the list the medical device through Medical Device Listing and reference the 510(k) which is "owned" by Company A. To answer your question, no you do not need to be considered the "legal manufacturer" or the Manufacturer of all components of the system. Your company, Company A, owns the 510(k) submission, lists your reagents linked to 510(k) K##. Company B making the instrument then lists their product linked to 510(k) K## - again recommend having a contract or agreement in place describing how all this works and functions, so that during a FDA inspection it is clear.
This strategy of submitting separate 510(k) applications also would be fine - though as a Class I device, does it actually need a 510(k) clearance? Because if the classification of the instrument is Class I by Regulation and Product Code, it actually makes the situation a bit easier. Because then the Manufacturer of the instrument lists their product on Medical Device Listing under their name as a Class I device. Then your company gets 510(k) clearance for the reagents and then lists own products on the Medical Device Listing. The 510(k) submission would identify the instrument which is used for the reagents, clearly stating the instrument is Class I per Regulation 8##.####, Product Code XYZ. Then how the product is sold or placed on the market in the U.S. is really business activity at that point not having so much regulatory impact. However, if the combination of the instrument and reagents require a 510(k) application, meaning because of indications for use the "system" is Class II, should be considered For the instrument then these can be submitted separately or combined as described above. The reason the instrument manufacturer would want their own listing or their own 510(k) clearance is if they are planning to sell to multiple companies. Hope that helps.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Aug-2022 07:42
From: Anonymous Member
Subject: IVD filling for 510K submission - strategy
This message was posted by a user wishing to remain anonymous
Hello Regex team,
We are planning on 510K submission for an IVD. We are the manufacturer of the reagent, but the instrument will be through a supplier. We are planning to combine it for our 510K sub.
- I believe that in this case, we will be the manufacturer of the whole system?
- Is that a better strategy or should we have the supplier perform the 510K/Class I submission (since we believe that the instrument alone might be a class I device) and we submit class II for the reagent only?
Thank you for any guidance!